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Key value for chemical safety assessment

Additional information

In vitro studies:

Diethylamine was evaluated for mutagenicity in the Salmonella/microsome preincubation assay using a standard protocol approved by the National Toxicology Program. DEA doses of 0, 33, 100, 333, 1000, 3333, and 10000 µg/plate were tested in four Salmonella typhimurium strains (TA98, TAl00, TAl535 and TAl537) in the presence and absence of Aroclor-induced rat or hamster liver S9. These tests were negative and the highest ineffective dose level tested in all four Salmonella tester strains under all treatment conditions was 3333 µg/plate. In a second Ames test conducted under NTP standard conditions (NTP, 2005), S. typhimurium TA 98 and TA 100 strains were treated with doses of 0, 50, 100, 250, 500, 750, 1000, 2000 µg/plate and E. coli WP2 uvr A pKM 101 with 0, 50, 100, 500, 1000, 2000, 3000, 4000 µg/plate (NTP, reliability score: 2) confirmed these negative results. In two further standard Ames tests with two strains (TA100, TA1535) or three strains (TA98, TA100, TA1538), diethylamine gave also no evidence of mutagenicity in the bacterium Salmonella typhimurium either in the presence or absence of a mammalian liver metabolic activation system (Hedenstedt, 1978; Khudoley 1987, reliability score: 2).

One negative gene mutation assay is also available, conducted in mammalian cells (L5178Y cells) according to the OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test) at test substance concentration range from 45.71 to 731.4 µg/ml with or without S-9 mix (Covane Laboratories Ltd., 2010).

 

In vivo studies:

In a micronucleus assay with B6C3F1 mice, peripheral blood samples were obtained from 5 male/female animals at the end of a 13-week inhalation toxicity study (6 hours per day, 5 days per week; doses of 0, 8, 16, 32, 62, 125 ppm). No significant increase in micronucleated NCEs was observed in males or females and all tested dose groups.


Short description of key information:
In vitro studies:
Ames-Test: negative (NTP study)
MLA Test: negative (Covance Lab. Ltd)
In vivo studies:
Mouse Micronucleus Test: negative (NTP study)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Four valid Ames-tests and one MLA test (with or without metabolic activation through S9-Mix), and one in vivo mouse micronucleus assay provided no evidence for a mutagenic effect of diethylamine.

Diethylamin CAS No. 109 -89 -7 is not warranted for classification and labelling according to Directive 67/548/EEC Annex I and

according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

No effects were observed in the underlying studies and in close strutural analogues.